About this journal

The Journal of Biopharmaceutical Statistics , a rapid publication journal, discusses quality applications of statistics in biopharmaceutical research and development. Now publishing six times per year, it includes expositions of statistical methodology with immediate applicability to biopharmaceutical research in the form of full-length and short manuscripts, review articles, selected/invited conference papers, short articles, and letters to the editor. Addressing timely and provocative topics important to the biostatistical profession, the journal covers:

• Drug, device, and biological research and development
  
• Drug screening and drug design
  
• Assessment of pharmacological activity
  
• Pharmaceutical formulation and scale-up
  
• Preclinical safety assessment
  
• Bioavailability, bioequivalence, and pharmacokinetics
  
• Phase, I, II, and III clinical development including complex innovative designs 
  
• Premarket approval assessment of clinical safety
  
• Postmarketing surveillance
• Big data and artificial intelligence and applications   

All submitted manuscripts are subject to initial appraisal by the Editors. If found suitable for further consideration, papers are subject to peer review by two independent, anonymous expert referees, each delivering at least one report under the guidance of a team of expert Associate Editors. All peer-review is single anonymous and submissions can be made online via the Submission Portal. 

Publishing Ethics Statement

The Journal adheres to the highest standards of publishing ethics, with rigorous processes in place to ensure this is achieved. Taylor & Francis is a member of the Committee of Publication Ethics (COPE) and utilizes Similarity Check for all Journals.

More information on our ethical standards and policies can be found here:

http://authorservices.taylorandfrancis.com/ethics-for-authors/.

The Journal has an appeals and complaints policy which can be viewed here:

https://authorservices.taylorandfrancis.com/peer-review-appeals-and-complaints-from-authors/

Editorial Board

Editor-in-Chief:

Wen Zhou
Associate Professor, Colorado State University
Fort Collins, CO 80523 USA
Email: [email protected]

Co-Editor:

Margaret Gamalo-Siebers, PhD
Statistics Therapeutic Area Head – Inflammation and Immunology
GPD-Inflammation and Immunology, Pfizer
500 Arcola Road
Collegeville, PA 19426 USA
email: [email protected]

Managing Editors:

Victoria Chang
Director, Global Statistics and Data Science
BeiGene, Ltd.
1840 Gateway Drive, 3rd Floor
San Mateo, CA 94404
Tel: 669-246-8342
Email: [email protected]

Xiaofei Bai
Associate Director, Biostatistics
Servier Pharmaceuticals
200 Pier 4 Boulevard
Boston, MA 02210
Email: [email protected]

Honorary Advisory/Editorial Board Members:

Stan Altan - Senior Director, Johnson & Johnson, Raritan, NJ
A. Lawrence Gould (Editor 2000-2002) - Senior Director, Scientific Staff, Merck & Co., Inc., Blue Bell, PA
Gregory Campbell - Director, Biostatistics, FDA/CDRH, Rockville, MD
Kevin J. Carroll - Statistical Consultant, KJC Statistics, Cheadle, UK
Vernon Chinchilli - Distinguished Professor, Pennsylvania State University, Hershey, PA
Lutz Edler - Former Head of Division, Biostatistics,German Cancer Research Center, Heidelberg, Germany
Dean Follmann - Chief of Biostatistics Research Branch, NIAID, National Institutes of Health, Bethesda, MD
Paul Gallo - Senior Biometrical Fellow, Novartis Pharmaceuticals, East Hanover, NJ
Samiran Ghosh - Associate Professor, Wayne State University, Detroit, MI
Lan Huang - FDA, Silver Spring, MD, USA
Farid Kianifard - Director, Biostatistics, Novartis Pharmaceuticals, East Hanover, NJ
Gary Koch - Professor, University of North Carolina, Chapel Hill, NC
Jen-Pei Liu - Professor, National Taiwan University, Taipei, Taiwan
Dirk F. Moore - Associate Professor, Rutgers University, New Brunswick, NJ
Annpey Pong - Principal Scientist, Merck Research Institute, Morris, NJ
Steve Snapinn-   Seattle-Quilcene Biostatistics LCC, Seattle, WA, USA
Roy Tamura - Associate Professor, University of South Florida, Tampa, FL, USA
Siu-Keung Tse -  Associate Professor, City University of Hong Kong, Kowloon, Hong Kong
Yi Tsong - Deputy Division Director, FDA/CDER, Rockville, MD, USA
David Wright - Head of Statistical Innovation, AstraZeneca, Cambridge, UK
Daniel Zelterman - Co-Director, Yale Cancer Center, New Haven, CT, USA

Book Review Editor:

Wenjin. Wang -  Senior Director, Pfizer Inc, Collegeville, PA

Associate Editors:

Yuki Ando - Senior Scientist, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
Carl-Fredrik Burman - Head of Quantitative Solutions, AstraZeneca, Mölndal, Sweden
Jie Chen - Head of Biometrics, Overland Pharmaceuticals, Warrington, PA, USA
Yeh-Fong Chen – Supervisory Mathematical Statistician, FDA/CDER*, Silver Spring, MD, USA
Alan Y. Chiang –Head of Biometrics, Lyell Immunopharma, Seattle, Washington, USA
Yi-Lin Chiu - Director and Department Head of Biometrics, AbbVie, North Chicago, IL, USA
Sumit Chopra - Associate Professor, New York University, New York, NY, USA
Tudor Cristea-Platon - Researcher, Apple Inc., Cambridge, MA, USA
Gaohong Dong -Director of Biostatistics, BeiGene Ltd., Ridgefield Park, NJ, USA
Vladimir Dragalin - Vice President and Scientific Fellow, Janssen Pharmaceutical Companies of Johnson & Johnson, Spring House, PA, USA
Haoda Fu - Associate Vice President, Eli Lilly and Company, Indianapolis, IN, USA
Pranab Ghosh-Director Biostatistics, Pfizer Inc, Acton, MA, USA
Samiran Ghosh - Associate Professor, Wayne State University, Detroit, MI, USA
Jiangtao Gou -Associate Professor, Villanova University, Villanova, PA, USA
Tony Xiang Guo - SVP, Global Statistics & Data Science, BeiGene, Ltd., Beijing, China
Chin-Fu Hsiao - Deputy Director/Investigator, National Health Research Institutes, Zhunan, Taiwan
Lihong Huang - Associate Professor, Fudan University, Shanghai, China
Jason C. Hsu - Professor Emeritus, Ohio State University, Columbus, OH, USA
Bo Jin - Vice President, Head of Data Science, Sumitomo Pharma Oncology, Inc, Marlborough, MA, USA
Man Jin - Director and Research Fellow, Statistics, AbbVie, North Chicago, IL, USA
Seung-Ho Kang - Professor, Yonsei University, Seoul, Korea
Meinhard Kieser - Director of the Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany
John E. Kolassa - Distinguished Professor, Rutgers University, Piscataway, NJ, USA
Mengxing Li - Senior Data Scientist, Insightin, Baltimore, MD, USA
Xiaoyun Nicole Li - Executive Director, BeiGene Ltd., San Mateo, CA, USA
Jianchang Lin – Senior Director, Statistics, Takeda, Cambridge, MA, USA
Junjing Lin – Senior Director, Biostatistics, Takeda, Cambridge, MA, USA
Nelson T. Lu - Assistant Director, Biostatistics, FDA/CDRH*, Silver Spring, MD, USA
Tao Lu - Assistant Professor, SUNY Albany, Rensselaer, NY, USA
Arnab. K. Maity - Senior Manager, Pfizer, San Diego, CA, USA
Gu Mi - Director of Biostatistics, Sanofi, Cambridge, MA, USA
Satoshu Morita - Professor and Chairman, Kyoto University Graduate School of Medicine, Kyoto, Japan
David Paulucci - Director of Data Science, Bristol Myers Squibb, Lawrenceville, NJ, USA
Matthew A. Psioda -Head of Statistical Innovation for Oncology and Vaccines, GSK, Philadelphia, PA, USA
Nusrat Rabbee -Chief of Biostatistics and Clinical Epidemiology, NIH Clinical Center, San Francisco, CA, USA
Patrick M. Schnell - Assistant Professor, Ohio State University College of Public Health, Columbus, OH, USA
Yodit Seifu - Director, Bristol-Myers Squibb, Berkeley Heights, New Jersey, USA
Meiyu Shen - Lead Mathematical Statistician, FDA/CDER*, Silver Spring, MD, USA
Jyh-Ming Shoung - Director, Jansseen R&D, Johnson & Johnson, Raritan, NJ, USA
Say-Beng Tan - Executive Director, National Medical Research Council, Singapore
Sophie Hsiao-Hui Tsou - Associate Investigator, National Health Research Institutes, Zhunan, Taiwan
Yi Tsong - Division Director, FDA/CDER*, Silver Spring, MD, USA
Jung-Ying Tzeng - Professor, North Carolina State University, Raleigh, NC, USA
Duolao Wang -Professor, Liverpool School of Tropical Medicine, Liverpool, UK
Li Wang - Senior Director and Head of Statistical Innovation, AbbVie, North Chicago, IL, USA
Ming Wang - Associate Professor, Case Western Reserve University, Cleveland, OH, USA
Susan Q. Wang - Senior/Principal Clinical Data Scientist, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA
Xin Wang - Senior Director, Bristol Myers Squibb, Berkeley Heights, NJ, USA
Tu Xu - Director of Biostatistics, Novo Nordisk, Lexington, MA, USA
Hou-Cheng Yang - Edwards Lifesciences, Irvine, CA, USA
Miao Yang -Statistician, Seagen Inc, Bothell, WA, USA
Bingbing Yu -Associate Director, Oncology Biometrics, AstraZeneca, Gaithersburg, MD, USA
Godwin Yung - Principal Statistical Methodologist, Genentech Inc, South San Francisco, CA, USA
Tianyu Zhan - Associate Director, AbbVie, North Chicago, IL, USA
Jing Zhang - VP, Head of Biometrics, Adela, Inc., CA, USA
Lanju Zhang - Senior Director, Vertex Pharmaceuticals, Newton, MA, USA
Communications Editors:

Yodit Seifu - Merck & Co., Inc., Kenilworth, NJ
Junjing Lin - Takeda, Cambridge, MA

Emerging Insights and Commentaries Editor:

Qian Helen Li -Department of Biostatistics, StatsVita, Bethesda, MD, USA

Past Editors:

Karl E. Peace (Founding Editor, 1990-1999) - Georgia Cancer Coalition Distinguished Cancer Scholar, Senior Research Scientist, and Professor of Biostatistics,Georgia Southern University, Statesboro, GA, USA
A. Lawrence Gould (2000-2002) - Senior Director, Scientific Staff, Merck & Co., Inc., Blue Bell, PA, USA
Shein-Chung Chow (2003-2019) - Professor, Duke University School of Medicine, Durham, NC, USA

News, offers and calls for papers

News and offers

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